Market Place
This week, SpeakPharma interviews Martin Meeson, CEO of
Axplora, a leading and
reliable API manufacturing partner to some of the world’s biggest pharma and biotech companies.
Meeson discusses Axplora’s expansion in the antibody-drug-conjugate (ADC)
space and how it is well-placed to serve the exciting market for glucagon-like
peptide 1 (GLP-1) drugs with its industrial footprint and purification
technologies across several sites.
🔑 HIGHLIGHTS// API manufacturing partner to some of the world’s biggest pharma and biotech companies
As a leader in the pharmaceutical industry, what
inspired you to join Axplora? And, what do you consider the most rewarding
aspect of your role as its CEO?
When you look at
Axplora as the custodian of strong brands like Farmabios, Pharmazell and
Novasep you cannot help but be intrigued by what such breadth of offering and
depth of technical expertise can achieve. Well, I was certainly intrigued!
As a leader in
the pharma space, the opportunity to guide an organization with several decades
of experience is inspiring for me. For example, our site in Leverkusen was
founded over 150 years ago by Alfred Nobel. With every meeting and site visit,
I get increasingly impressed by the capabilities of the people that I meet.
Now, it is my job to make sure that these capabilities are given the best opportunity to serve.
In this sector,
we have the privilege of working with our partners to supply and develop
medicines that have such a positive impact on people’s lives. This for
me is the most rewarding thing that we do. Sometimes the work that we do can
seem a little far away from the patient. I always take time to remind myself,
my staff, and hopefully also your readers of what we are doing and how our work
impacts others.
🔑 HIGHLIGHTS// strong brands like Farmabios, Pharmazell and Novasep / positive impact on people’s lives
How have recent industry developments influenced
both API manufacturing and CDMO sectors, and what specific strategies has
Axplora implemented to adapt to these changing market dynamics while
maintaining its commitment to quality and innovation?
As a CDMO, when
you partner with us, there is always a focus on reliable supply, and we are
still haunted by the challenges all of us faced during the pandemic. At
Axplora, we have implemented numerous initiatives to increase the robustness of
supply, particularly in looking at advances in sourcing and horizontal
integration both within and across our network. At the same time, we have a
strong focus on the impact that we are having on the planet and Axplora’s work in this area is tremendous — from increasing the amount and efficacy of waste management, notably the current programs around solvent recovery and recycling, to implementing more environment-friendly technologies such as electrochemistry. I am particularly excited by the cutting-edge work on moving to completely new processes that are water-based rather than solvent-based, creating a step change in impact for us and our partners.
In addition, as a
CDMO you have to constantly look at where your services fit within evolving
markets. Axplora’s expansion in
the ADC sector is an excellent example of tracking and investing in emerging
technologies. Of note also is the current demand for GLP-1 medicines, and
Axplora is well-placed to serve this exciting market with our industrial
footprint in small molecules and purification technologies across several sites
in our network.
🔑 HIGHLIGHTS// increase the robustness of supply / efficient waste management programs and environment-friendly technologies
Can you discuss any recent advancement or breakthrough in API manufacturing or CDMO services at Axplora that have contributed to the company’s success?
Our investment in
ADC expansion is a key strength. Our Novasep business has some of the world’s leading
capabilities in API manufacturing and purification. It is known worldwide for
these capabilities. With increasing demand for GLP-1 drugs and the amazing
impact they are having on patients globally, we are ready to support this
growth across our extensive network. The race to oral dose medicines in this space is particularly exciting, and Axplora
is looking forward to treating the vast patient population in diabetes and
obesity.
🔑 HIGHLIGHTS// expansion in the ADC sector / treat the vast patient population in diabetes and obesity
Looking ahead, what are some of the trends or
developments you foresee in API manufacturing and CDMO services, and how is
Axplora preparing to stay ahead of the curve in this ever-evolving
pharmaceutical landscape?
Whilst the
landscape is evolving rapidly, regulations are not necessarily able to keep
pace with the development of new molecules. The pandemic revealed that things
can move more quickly. When I look at the challenging new regulation in
adjacent spaces like cell therapy, I wonder how that pace can be applied to our
sectors. To that end, you have to remain agile and responsive to customer
needs. We have to ensure we invest to
grow our capacity in the right areas. Our recent investments in Farmabios in
Gropello Cairoli (Italy) to support our thriving steroids business and in
Pharmazell in Vizag (India) to advance our specialty business are clear
indications of how we can do this very successfully.
It would be
easier if I could point to just one thing that we are doing, but that is not
how we win. The only way to stay ahead
is by making a myriad of large and small adjustments and evolutions and that is
where the Axplora group excels.
Finally, one
element I should mention is that we are part of a global supply chain.
Therefore, our broad network stands ready to supply medicines to multiple
geographies. Our investments reflect our worldwide customer base and ambitions.
We are here to serve our partners and their patients.
🔑 HIGHLIGHTS// recent investments in Farmabios in Italy and Pharmazell in India / ready to supply medicines to multiple geographies
Impressions: 2175
https://www.pharmacompass.com/speak-pharma/axplora-s-leading-position-in-adcs-and-how-it-is-well-placed-to-serve-the-burgeoning-glp1-market
#SpeakPharma with Axplora
23 May 2024
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This week, SpeakPharma interviews Anne-Laure Gaudry, Head of Innovation and R&D at HTL Biotechnology, a global producer and developer of pharmaceutical-grade biopolymers. Anne-Laure Gaudry discusses the story of HTL Biotechnology, the evolution of the biopolymer market, and HTL’s innovation and R&D strategy.
🔑 HIGHLIGHTS// pharmaceutical-grade biopolymers/ CDMO
Can you briefly take us through the history of HTL Biotechnology?
From the very beginning, HTL
Biotechnology distinguished itself from the rest through its bacterial
fermentation manufacturing method, as also its hyaluronic acid produced in
fiber form. These are proof of our uniqueness, very high product quality, experience
and the unique know-how of our teams.
For over 30 years, HTL Biotechnology has been producing hyaluronic acid (HA) for some of the biggest names in the pharmaceutical industry. World-renowned expertise and unwavering commitment of HTL Biotechnology’s teams has helped the company grow significantly over the years.
Since 2003, HTL Biotechnology
has embarked on a process of improving its manufacturing facilities and final
purification stages. This has significantly increased the purity of the
pharmaceutical grade HA that we produce.
To consolidate the laboratory’s lead in the market in terms of product quality, HTL Biotechnology invested heavily in training, quality control and better equipment.
In 2014, to keep pace with demand and to ensure HTL Biotechnology’s long-term growth, the Javené site (Brittany, France) was considerably expanded. At the same time, HTL Biotechnology continued to strengthen its teams, infrastructure, and equipment, notably through the acquisition of new fermenters with greater capacities.
Over the years, HTL
Biotechnology has become the world leader in pharmaceutical grade biopolymers
and a unique force in innovation.
To bring innovation for its
customers in historical applications (aesthetics, rheumatology, ophthalmology)
and to pave the way in new therapeutic applications (drug delivery,
regenerative medicine, microneedling, ocular drug delivery and bioprinting), HTL
Biotechnology decided to invest in the construction of an R&D laboratory, called HTL3, in Javené, France.
Inaugurated in 2018, this state-of-the-art laboratory symbolizes the company’s R&D ambitions, to push the boundaries of the use of HA to meet unmet medical needs.
🔑 HIGHLIGHTS// manufacturing HA for 30 years/ hyaluronic acid in fiber form/ Javené site expansion/ regenerative medicine, microneedling, ocular drug delivery and bioprinting
How has the market for biopolymers evolved over the years?
As the world became more
aware of the environment and began moving towards sustainability, the demand
for biopolymers increased. In the pharma sector, biopolymers began to see
substantial use in drug delivery methods to finetune efficacy.
Biopolymers are an important class of materials because of their biodegradability — they work well with the body, are safe, don’t trigger immune responses, stay in the bloodstream for a long time, and can carry a high amount of both large and small drug molecules.
The quality of hyaluronic acid has always been a priority for HTL. The first few years of our activity in biotechnology — i.e. between 1992 and 1998 — were a period of finetuning the methods for producing HA by bacterial fermentation, in order to find the parameters that would ensure the best possible quality for use by the pharmaceutical industry. Since then, HTL Biotechnology’s quality teams have set up a quality management system. Today, we are ISO 14001 certified.
Over the past few decades,
various methods and procedures for producing biomaterials have emerged that aim
to understand and replicate the crucial structural and compositional features
of natural tissues.
We’ve been using bacterial fermentation to produce HA since the early 1990s and are one of the most experienced companies in this space.
Today, raw materials of
animal origin are no longer needed to produce HA, thereby preserving natural
resources. Over the last few decades, our HA has changed the lives of millions
of people around the world.
🔑 HIGHLIGHTS// DDS/ biodegradability/ don’t trigger immune response
In 2021, the company opened a new bioproduction unit in France. Tell us
how the market for HA is growing, and how the new unit has contributed to
growth.
We have unparalleled
expertise in producing premium quality HA. We had been experiencing
double-digit growth and international expansion prior to setting up of the new
bioproduction unit in France. Therefore, we strategically made the largest
investment ever for a biopolymer production unit.
The over €50 million (US$ 53.52 million) investment in HTL4 signifies the culmination of HTL Biotechnology’s biomanufacturing expertise, setting a new standard for innovation and infrastructure quality. Cutting-edge technologies at the plant enable production lines to be automated and digitized, guaranteeing historic quality of production. From the outset, we took a strategic decision to reduce the environmental impact of our activities while guaranteeing reliability.
This unit has more than doubled our production capacity, allowed us to accelerate international development and emerge as the world’s largest producer of pharmaceutical-grade HA. Finally, HTL4 has secured the supply of our customers in over 30 countries and helped many leading pharma companies offer innovative therapeutic solutions to their patients worldwide.
🔑 HIGHLIGHTS// double-digit growth/customers in over 30 countries/ €50 million investment
HTL Biotechnology also has a 45-year track record in producing DNAs.
Which applications require DNAs? And what goes behind DNA production?
We are identified with our
quality, safety and efficacy. The market has recognized us for being able to
provide pharmaceutical-grade DNA for both topical and injectable applications,
with a high level of purity, biocompatibility and efficacy, owing to our gentle
production process designed to protect the double-strand structure of a DNA.
All our products are GMP compliant.
Polynucleotides have
pharmaceutical uses in aesthetics. They help increase collagen production in
the skin and maintain its elasticity. Polynucleotides also promote fibroblasts
proliferation that are essential for wound healing. PDRN is a drug used to reduce
inflammation caused by UVA and UVB, and it also reduces oxidative stress in
cells. We also produce sodium DNA, our cosmetic grade DNA used in products like
regenerating mask, serum, cream and repairing cream.
🔑 HIGHLIGHTS// topical and injectable applications/ high level of purity/ help increase collagen production in skin and maintain its elasticity
What are some of the objectives of your R&D strategy?
Innovation is at the heart of our strategy. Our specialist teams work seamlessly to drive innovation. We believe biopolymers are central to tomorrow’s therapeutic innovations and have the potential for infinite applications in many therapeutic areas. Our strategy is to innovate for the benefit of our customers and their patients through the development of increasingly avant-garde and high-performance biopolymer platforms.
Today, HTL Biotechnology produces over a hundred ‘custom-made’ HAs for its customers. We have developed several new products, such as silanized HA and methacrylate HA. With chemical functionalization, new properties and characteristics can be added to the polymer. HTL Biotechnology’s functionalized biopolymers business enables the development of tailor-made products that can be manufactured on an exclusive basis, from process development to GMP production. These processes can be used to create the HAs of tomorrow.
🔑 HIGHLIGHTS// development of increasingly avant-garde and high-performance biopolymer platforms
What are some of the new growth areas HTL Biotechnology is looking at ?
There are some very exciting possibilities for HA in a few rapidly developing technologies like bioprinting and microneedle patches. Today, one million people in the world are awaiting transplants. Can you imagine the possibility of creating organs?
Bioprinting is the biological
equivalent of 3D printing. HA is one of the substances used for bioprinting.
The technology allows us to imagine a fantastic area for expansion.
Moreover, we are looking at
intradermal vaccine delivery, thanks to dissolvable needles that are barely
visible to the naked eye and are made of HA. We are also working on innovation
in other areas such as oncology, rheumatology and odontology.
🔑 HIGHLIGHTS// possibility of creating organs?/ 3D printing/ intradermal vaccine delivery/
Over the last few years, HTL Biotechnology has set up an affiliate in
Asia. How have these affiliates contributed to the growth of HTL Biotechnology?
In 2022, we established an Asian subsidiary, and this can be seen as a mark of the company’s ongoing global expansion and dedication to serving healthcare customers across all Asian countries. Operating from Singapore, HTL Biotechnology Asia will bring the company closer to its clients and ensure unparalleled support. Also, our teams in Korea and China are focused on engaging with our existing clients, forging new business relationships, and exploring opportunities for expanding our market presence in these regions.
🔑 HIGHLIGHTS// Asian subsidiary, in Singapore
What are the company’s long-term growth plans? Are you looking at expanding your global presence?
Our story has only just
begun. By 2030, we expect our innovative biopolymer platform to benefit over
500 million patients worldwide suffering from ocular, rheumatological, aging
diseases and other diseases with the development of new applications.
Our future involves a global
expansion, from the United States to Asia, with stronger teams in France, an
ever-increasing number of applications for our biopolymers, and the constant
creation of new and innovative biopolymers, thanks to our R&D investments.
We look at HTL Biotechnology as a global company with a heart in Brittany,
France.
🔑 HIGHLIGHTS// 500 million patients/ ocular, rheumatological and aging diseases/ global expansion to the US and Asia/
Impressions: 1086
https://www.pharmacompass.com/speak-pharma/through-innovation-we-ve-emerged-as-world-leaders-in-biopolymers
#SpeakPharma with HTL Biotechnology
01 May 2024
This week, SpeakPharma interviews Alexandre Williams, owner and director of Athena Pharmaceutiques, which is a trusted partner of choice to source differentiated branded generics in the pharmaceutical sector. Williams discusses the importance of research and development (R&D) to deliver cutting edge medical solutions to the international market, and the strategy behind choosing India to expand its R&D operations.
🔑 HIGHLIGHTS// branded generics/ innovation/ forward thinking/ CDMO/ France/ India
Athena Pharma has come a long way since it was first spun off from its parent company — Ethypharm — in 2011. The growth has been particularly remarkable over the last three years. Tell us how the company has managed to scale new heights during and post the Covid-19 pandemic?
We’ve been expanding operations in emerging markets since 2012, while also not ignoring developed markets. In 2017, we launched products in Europe, Canada, and the UK among other markets. So, we’ve been on a roll.
Covid had, in fact, a small impact on our activity. It did slow down some R&D and expansion projects. However, given our broad portfolio with allergy, anti-emetic and pain relief products, we saw an increase in sales during the pandemic.
In fact, 2020 was a big year for us. We acquired our first European factory in France — Athena IPS, set up our first office in Canada, and bought an effervescent technology. In 2022, we acquired the brand Secnol (secnidazole) and launched a new R&D facility in India.
Compared to Covid, we saw the European energy inflation crisis as a bigger threat, given the continent’s reliance on Russia for energy. Russia’s invasion of Ukraine and the expected sanctions on Russian imports meant that energy costs were going to skyrocket and create a massive turmoil in the supply chain. Those repercussions were felt by the market and our clients.
Our growth is fueled by our extensive portfolio of products. We have a huge number of launches planned in Brazil and pretty much every emerging market. Indeed, we will see over 100 new launches in the next two years.
🔑 HIGHLIGHTS// EU/ UK/ factory in France/ new office in Canada/ new R&D unit in India/ effervescent tech/Secnol acquisition
How is the market for branded generics growing? How is Athena creating a differentiation within this market to prolong the life of well-established products through improved drug delivery systems?
As mentioned, the pandemic was a booster for the branded generics market. As healthcare systems the world over scrambled to meet needs, accessibility and affordability that come with branded generics made them even more crucial. Furthermore, global supply chain disruptions led to a shift toward manufacturing locally and regionally produced branded generics. India has emerged as the largest generic supplier in the world. And with its growing population, the demand for affordable medication has also grown.
Branded generics are best supported with improved formulations. By offering a better, different or new product, our partners can market differentiated products that are set apart from competition. The differentiation must really bring an improvement in terms of delivery, compliance, taste or dosing. Only real lifecycle advantages make a difference, but it also must be cost effective to allow our partners to push sales of these new brand generics.
🔑 HIGHLIGHTS// pandemic boosted branded generics market/ India emerged as largest generic supplier
How important has R&D been to the company’s objective of delivering cutting-edge drugs? What steps have to be undertaken to ensure Athena’s commitment and dedication to R&D?
Innovation has always been central to Athena’s DNA, right from our humble beginnings. The mission was to leverage great research and development (R&D) to deliver cutting edge medical solutions to the international market.
We have invested steadily since our inception, including an investment in 2021 that led to opening up of our French R&D center. A year later, our new R&D center came up in Mumbai, adjacent to our Indian factory.
Personnel is key and I must say that I am highly proud of our R&D team. Building a good team takes time and effort. No R&D department can function without the right people.
🔑 HIGHLIGHTS// innovation/ team work/ right people
Athena has expanded its global presence (in markets like Brazil, Canada and China) in recent years. How have these expansions contributed to growth?
Different geographies come with different situations, needs, demographies, and healthcare challenges. This forces us to adapt our technology to create products of interest in each of those territories. When we successfully pull off a product lifecycle in one market, we can take what we learned and make that product a huge success in other markets.
For instance, in Canada we developed a generic zolpidem tablet for insomnia that disintegrates under the tongue. We then adapted it and positioned it as branded generic for Latin America and Europe and saw great success.
🔑 HIGHLIGHTS// different geographies — different needs
How have dosage forms like oro-dispersible and modified release formulations performed? Have you added more drugs to these dosage forms?
Oro-dispersible tablets (ODTs) are like conventional tablets with super disintegrants that dissolve in the mouth within minutes. ODTs have made it easy to administer medication, especially in pediatric, geriatric, and mental illness populations. This makes them a very popular dosage form. Improved patient compliance, rapid onset of action, and improved stability are some of the advantages we’ve seen. Athena’s Fastmelt technology has rendered it a leader in the ODT space.
Modified drug release protracts the drug’s release into the bloodstream or to a specific target and this means they can be taken at less frequent intervals. We’ve seen an increase in patient convenience, compliance, and thereby improved efficacy. Sustained release (SR) products sustain the level of a drug in the bloodstream and reduce adverse effects.
Indeed, we had developed many ODTs, taste masked and SR products. But what amazes me is that every time you are afraid that those matured technologies will become outdated, they don’t, and we have endless new developments to be carried out.
🔑 HIGHLIGHTS// ODTs for pediatric, geriatric, and mental illness/ SR drugs sustain level in bloodstream, reduce side effects
What are some of the fastest growing drug release mechanisms? How is effervescent technology performing?
As I mentioned, we are seeing speedy growth in drug delivery technologies. Fixed dose combinations are products of two or more drugs in a single dose. The simpler dosing schedule leads to excellent patient compliance, and it is among the fastest growing drug release mechanisms.
Effervescent technology is widely used in Europe, and worldwide it is used to deliver vitamins. The technology is of particular interest when it comes to products that need to be solubilized and drugs that absolutely need to be taken with water. However, effervescent technology is underdeveloped in emerging markets and only used for over-the-counter (OTC) or food supplement products. There are many new formulations that can use effervescent technology, so we can easily expand.
🔑 HIGHLIGHTS// effervescent tech for vitamins/ yet to pick up in emerging markets
What are some growth plans of Athena? Where do you see the company in the next five years?
Our new target markets for the coming years are China and the US, where we aren’t as active at present. As far as growth goes, the most critical aspect is identifying the product that is to be developed. So, our goal in the coming years is to enrich our portfolio of products that bring real value to people and their quality of life. Ideas are welcome!
🔑 HIGHLIGHTS// China/ USA/ expand portfolio
In terms of drug delivery technologies, Athena has come up with some groundbreaking solutions. Could you please tell us how these may be game-changers in the lives of patients?
These days, there is a lot of talk about revolutionary biotechnologies like ARNm (advances in radiotherapy and nuclear medicine) and CAR-T therapies, which specifically target and eliminate cancer cells more effectively. But we should not underestimate the crucial role our drug delivery technologies play, particularly in enhancing medication acceptance and compliance. They hold immense potential and remain an integral part of the healthcare landscape because we offer cost-effective and impactful solutions that improve patient outcomes.
🔑 HIGHLIGHTS// enhancing medication acceptance and compliance/ cost-effective and impactful solutions
Can artificial intelligence (AI) and machine learning help in discovering new drug delivery technologies? If so, then how?
They can certainly help in pharmacodynamics (effects of drugs and the mechanism of their action). In the in vivo vitro correlation, which is the predictive mathematical model that describes the relationship between the in vitro property of an oral dosage form and the corresponding in vivo response, Al can help gain a better understanding of the drug’s release or dissolution and the amount absorbed.
AI can help optimize and perhaps even individualize timing and dosage. It can analyze patient data, health records, geographical locations, medical literature, and patient demographics to match patients for clinical trials and monitor the trials for adverse events. Such real-time analysis can increase patient safety and help researchers assess how individual patients respond. It can help design formulations and select which technology serves the patient best. The use of AI will be massive, and we are just starting to use it.
🔑 HIGHLIGHTS// pharmacodynamics/ optimize and perhaps even individualize timing and dosage/ patient safety
What were the factors that helped Athena choose India for its expansion, particularly for R&D?
R&D power is really what makes Athena different, and it is thanks to our Indian staff who are experienced and well trained in pharmaceutical development. So, we chose India mainly for excellence in drug delivery and knowledge of pharmaceutical development. And not just for cost-effectiveness.
The Indian skill and competence are enhanced by the fact that Athena is active in so many markets from Europe and Canada to Brazil, Russia, and Asia. So, competence and experience required in those pharmaceutical markets is being acquired by our Indian personnel. The country is also doing a lot to ease foreign entry into its pharmaceutical industry like reducing timelines for facility approval.
🔑 HIGHLIGHTS// India: Excellence in pharma knowledge for DDS development
Impressions: 2061
https://www.pharmacompass.com/speak-pharma/athena-s-r-d-prowess-is-its-key-differentiator-with-our-india-unit-bringing-in-excellent-knowledge
#SpeakPharma with Athena
19 Apr 2024
This
week, SpeakPharma interviews Selwyn
Lustman, Senior Vice President, Global Sourcing and Procurement, LGM Pharma, a tailored active
pharmaceutical ingredient (API) and contract development and manufacturing
services provider (CDMO) for the full drug product lifecycle. Lustman discusses
the kind of regulatory support LGM provides its clients, while also talking about
its methodology for selecting the optimum source of APIs for its clients.
Can you briefly take us through the history of LGM Pharma?
We were established in 2005, and since inception we have been on a dedicated mission to excel in the sourcing and distribution of top-tier APIs, offering comprehensive API supply chain solutions spanning R&D to commercialization.
In 2020, LGM
Pharma acquired the formulation development and drug product manufacturing
business of Nexgen Pharma, Inc. This acquisition merged LGM’s global leadership in API sourcing, distribution, and supply chain management with Nexgen Pharma’s comprehensive drug product CDMO services.
What are some of the risks involved in sourcing APIs? And how can drugmakers manage these risks?
The primary challenges associated with API sourcing encompasses quality and regulatory considerations, necessitating the assurance of a material source aligned with the specific quality and regulatory standards applicable to the ultimate dosage product launch.
Efficient supply chain distribution hinges on establishing a collaborative partnership with a manufacturer capable of seamlessly supporting the entire spectrum, from early research and development (R&D) stages to the culmination of full-scale commercialization.
Price considerations also come to the fore, demanding that the chosen manufacturer not only meets but surpasses safety, environmental, and health requirements. Working with a seasoned sourcing partner serves as a proactive measure to mitigate these risks, as such a partner brings forth invaluable expertise to navigate the intricate landscape of regulatory and quality guidelines.
What kind of regulatory support do you provide your clients?
LGM Pharma offers a comprehensive suite of regulatory expertise to its clients, encompassing a spectrum of critical services. This includes evaluation of active substances and the meticulous technical writing and compilation of US Drug Master Files.
Throughout the
development process, LGM provides expert regulatory CMC (chemistry,
manufacturing and controls) compliance guidance, overseeing the writing and
assessment of quality/CMC regulatory documents (Module 2 and 3).
LGM Pharma ensures seamless coordination with clinical trial partners to guarantee eCTD (electronic common technical document) compliance (Module 5) and conducts critical writing and reviews of drug substance and drug product documentation.
LGM’s commitment extends to adherence to Code of Federal Regulations and guidance documents, ensuring the timely approval of new abbreviated new drug applications (ANDAs), amendments, and post-approval changes.
LGM Pharma also exhibits agility in responding to inspection requests (IRs) and commitment resolutions (CRs) prior to due dates, engages in regulatory authority interactions, including serving as a US agent, and conducts regulatory compliance gap analyses with adept issue resolution. Additionally, LGM conducts scientific, regulatory, and due diligence review of regulatory documents and submissions, reinforcing its commitment to regulatory excellence.
LGM Pharma has a strategic approach to API sourcing. Can you throw some light on this approach, and its benefits to your clients?
LGM Pharma distinguishes itself from conventional distributors by adopting a unique approach – one that sets it apart in the industry. Unlike distributors aligned with specific API manufacturers, LGM takes on a consultative role, prioritizing the representation of its clients’ interests.
Operating as a trusted advisor, LGM actively seeks out the optimal source of API for clients to serve as their primary drug substance supplier. In contrast to distributors affiliated with particular manufacturers, who inherently advocate for their associated companies, LGM positions itself as an unbiased entity capable of objectively confirming the selection of the best manufacturer. This client-centric approach ensures a discerning and tailored choice in the dynamic landscape of pharmaceutical ingredient sourcing.
What role does logistics play in API sourcing? How does LGM Pharma help out its clients with regulatory compliance?
Logistics plays a critical role in API sourcing, influencing the efficiency, reliability, and regulatory compliance of the supply chain. LGM Pharma, as a specialized pharmaceutical ingredient supplier addresses these logistics challenges in the following ways:
- Supply chain management: LGM is
involved in managing the end-to-end supply chain, ensuring the timely and
secure movement of APIs from manufacturers to clients. This involves
coordinating transportation, handling custom clearance, and optimizing inventory
levels to prevent disruptions to the supply chain.
- Quality assurance in
transportation: Given the sensitivity of pharmaceutical APIs, LGM implements
stringent quality assurance measures during transportation to maintain the
integrity of the APIs.
- Regulatory compliance: LGM assists clients in navigating the complex regulatory landscape associated with API sourcing. This includes adherence to GMP regulations, compliance with international standards, and ensuring that the transportation and storage of APIs meet regulatory requirements.
- Documentation and record keeping:
LGM maintains detailed documentation related to the transportation and handling
of APIs, facilitating regulatory audits and compliance checks. Accurate
record-keeping is essential for demonstrating compliance with regulatory
guidelines.
Impressions: 2758
https://www.pharmacompass.com/speak-pharma/lgm-operates-as-a-trusted-partner-by-seeking-out-optimal-source-of-apis-for-clients
#SpeakPharma with LGM Pharma
13 Dec 2023
This week, SpeakPharma interviews John McDermott, Vice
President of Scientific Consulting at Quotient Sciences, a drug development and manufacturing accelerator. McDermott highlights how pharma and biotech companies can leverage Quotient’s integrated services to improve the development of small molecule therapeutics in oncology. He discusses benefits of evaluating targeted oncology molecules in healthy volunteers, and how Quotient Sciences has applied its Translational Pharmaceutics® platform to accelerate drug product optimization.Tell us about Quotient Sciences’ experience with oncology drug programs.There is a growing demand for new and improved oncology treatments and it is important to streamline drug development processes so that new treatments can reach those in need.Over the last decade, Quotient Sciences has delivered over 400 projects with oncology drugs. This includes over 80 clinical programs with healthy volunteers. These clinical programs include first-in-human single-ascending-dose/multiple-ascending-dose, relative bioavailability, and 14C human absorption, distribution, metabolism, and excretion (ADME) programs.Using our flagship platform for drug development — Translational Pharmaceutics® — we are able to integrate drug substance synthesis, drug product and clinical testing activities within a single provider. This integration removes the white space that traditionally exists between these functions.By deploying Translational Pharmaceutics®, we are able to reduce development timelines by 12 months or more. This way, we are able to help our global pharma and biotech customers minimize risks while saving time and costs.Can
you explain how Translational Pharmaceutics reduces the drug development
timeline?Translational Pharmaceutics® allows the time between drug product manufacture and clinical dosing to be reduced from months to days, thereby reducing hold times whilst also enabling a ‘real-time’ approach to manufacture, as driven by clinical need.Recently, an oncology program of a customer involved
accelerated conduct of a first-in-human study. The investigational drug was
poorly soluble. In just 12 months, we were able to develop multiple formulation
options to overcome the solubility limitation, and switch development to a
product suitable for chronic administration in patient trials.What
are some of the challenges with accelerating new drug application (NDA)
timelines?The ongoing battle against cancer requires novel
approaches to accelerate the clinical trial process. Accelerated approval
pathways, which allow the NDA application process to commence from phase 2
onwards, require early submission of a high-quality chemistry, manufacturing,
and controls (CMC) package. This push to expedite timelines only increases the
risk of commercializing a drug substance and drug product production process
that is not fully optimized or scalable.Our approach involves an early understanding of the biopharmaceutical properties of the drug early in the development process, combined with expertise in process chemistry, analytical technology, and formulation development. By gaining early insight into the compound’s druggability, we mitigate risks in subsequent development phases.Application of Translational Pharmaceutics® to support formulation screening and optimization of drug product allows us to ensure rapid and flexible delivery of scalable drug products that meet the therapeutic need. This guarantees a high-quality CMC package that aligns with the accelerated approval process for oncology trials.How has Quotient Sciences used healthy volunteer clinical trials in oncology?We’re increasingly seeing that emerging modalities such as immunotherapy and new chemical entities (NCEs) are presenting challenges in terms of physical form, morphology, and chemical complexity.Drug product optimization is a crucial step to ensure downstream clinical success in patients. In this process, drug developers may look to increase oral bioavailability and solubility, reduce pharmacokinetic (PK) variability, overcome food effects, avoid adverse events, and reduce dosing frequency by switching administration routes or by switching to a modified-release form.For oncology drug programs, these challenges can be magnified, as dosing is typically performed directly in patients in phase 1, rather than by conducting healthy volunteer studies to establish safety and PK data. The approach of going directly into patients is known to be inherently problematic when it comes to the speed and effectiveness in identifying improved formulations to deliver improved PK profiles.The Translational Pharmaceutics® platform removes the white space in development by enabling real-time drug product manufacturing to be integrated with clinical assessments, reducing stability data requirements and batch sizes, and accelerating program delivery.Under Translational Pharmaceutics®,
drug products can be manufactured, released, and dosed in days. Rapid access to
real-time human clinical data from one study period determines the formulation
composition that is then made and dosed in the next. We’ve found that studying oncology molecules in healthy volunteer studies, where safe to do so, can often mean that study recruitment is not as complex. It can be achieved faster, and cohorts can be dosed together to improve formulation decisions. This also reduces or completely removes the variability in clinical data due to disease state. Moreover, the studies become more cost-effective to conduct.
Impressions: 1712
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#SpeakPharma with Quotient Sciences
07 Dec 2023
This week, SpeakPharma
interviews Dr. N.V. Rao, Chairman and Managing Director of Hyderabad (India)-based Metrochem API, one of the fastest growing manufacturers of active pharmaceutical ingredients (APIs), pellets and intermediates. Dr. Rao talks about Metrochem API’s strong core values and how the company has put in special efforts to meet the needs of the under-cared and neglected communities, with a clear view on sustainable health for all.Can you briefly take us through Metrochem API’s journey?
When we embarked on this extraordinary journey in 2004, armed with
my expertise in organic chemistry, our vision was unwaveringly clear. We aimed
to establish a company that would manufacture top-tier APIs of exceptional
quality, all while maintaining cost-effectiveness. Our goal was to cater to the
pharmaceutical industry's global needs and position Metrochem as the premier
supplier of APIs to customers worldwide.
Since our inception, we've strongly believed in creating value
through vertical integration. This belief has driven us to continuously invest
in infrastructure and manpower, ensuring an abundant supply of key starting
materials (KSMs), intermediates, and essential raw materials. Our six state of
the art manufacturing facilities are designed and operated in line with this
risk mitigation vision. We consider ourselves a pure-play API manufacturing
company with an acute awareness of the technical challenges facing the
healthcare industry.
Our focus has always been on expanding our product portfolio to
meet the diverse demands and challenges of the global landscape. We've
successfully built a robust product portfolio comprising over 190 products
spanning more than 30 distinct therapeutic segments. We excel in handling a
variety of niche products that require intricate chemical processes and pose
significant challenges, elevating them beyond the typical niche category.
Metrochem's journey, from my perspective, has been a relentless pursuit of excellence, innovation, and a commitment to serving the global pharmaceutical industry with integrity and dedication.
What are some of the key reasons behind Metrochem API’s success?Our
success is credited to our culture, which is founded on innovation, integrity,
customer-centricity, and safety. These principles guide every Metrochem team
member, and we take immense pride in consistently exceeding expectations.At
Metrochem, our organization's foundation is built upon our core values, which
we affectionately refer to as "LEADER." Within this framework, 'L'
signifies our dedication to 'Learning aspiration,' 'E' embodies our perpetual
pursuit of 'Excellence,' 'A' represents our 'Action-oriented' approach, 'D'
symbolizes our commitment to 'Discipline,' 'E' underscores our steadfast
dedication to 'Ethics and integrity,' and 'R' stands for 'Respect.'We
maintain a strong commitment to ethical behavior and actively pursue our social
responsibilities. We extend respect to every individual, and consider our
stakeholders cherished members of our extended family. Building meaningful
relationships with our customers, colleagues, and suppliers is an integral part
of Metrochem's identity. These values are deeply ingrained within Metrochem,
and guide our daily operations.This
robust value system drives our passion for continual growth and
self-improvement, both on an individual and at an organizational level. Our
enthusiasm is channeled towards achieving operational excellence, with a
primary focus on innovation and cost efficiency, all while upholding unwavering
quality standards.How has your manufacturing setup grown over the years?
Which regulatory authorities have recognized your efforts?Our
journey began with a single API facility in Hyderabad, accredited with WHO-GMP,
where we initially manufactured two APIs. By 2009, this facility had
successfully met the rigorous regulatory standards set by the Pharmaceutical
and Medical Devices Agency (PMDA) in Japan. In subsequent years, we not only
maintained our WHO-GMP accreditation but also earned recognition from the US
Food and Drug Administration (FDA) and COFEPRIS (Mexico Health Authority) in
2013. In 2014, we obtained accreditation from the Korea Food and Drug
Administration (KFDA), which is now known as the MFDS (Ministry of Food and
Drug Safety).We
prioritize adhering to strict regulatory compliance standards. Our commitment
is demonstrated through our willingness to undergo regular inspections by
esteemed international and national regulatory authorities, including the
USFDA, PMDA, WHO-GMP, ANVISA (Brazilian health regulator), and the European
Directorate for the Quality of Medicines and Healthcare (EDQM), among other
reputable bodies. These recognitions have played a pivotal role in elevating
our position as a leading bulk drug manufacturer in India.We
are grateful for the regulatory progress we have achieved over the years. At
present, Metrochem has submitted 56 US Drug Master Files (USDMFs), 21
Certificates of Suitability (CEPs), and numerous other significant regulatory
filings. Notably, we earned the global top ranking for the number of API USDMFs
filed in 2022.We
currently operate with six state-of-the-art manufacturing facilities located in
the states of Telangana and Andhra Pradesh, boasting of a total reactor volume
exceeding 3000KL. These manufacturing plants are backed by three cutting-edge,
centrally located research and development laboratories, along with a pilot
plant designated for testing and development purposes.What are Metrochem API’s target markets? How do you contribute towards sustainable healthcare?Currently,
we are fulfilling pharmaceutical needs across over 60 countries. Unlike the
typical focus on developed markets, our dedication extends to addressing
healthcare inequalities not only in developed markets but also in the
underserved, marginalized communities, and less developed nations. Our
overarching vision centers on promoting sustainable access to healthcare for
everyone.Our partners often say that “quality and affordability go hand in hand at Metrochem”. This has been possible due to our vertically integrated supply chain and our robust manufacturing process that we establish during the initial stages of product development. These processes allow us to not only match the desired specifications of our customers but also give us ample space to stay reasonable in terms of pricing, without hampering the quality standards.We
have a wide-reaching market presence that covers diverse geographical regions,
including India, the United States, Europe, South East Asia, the Middle East,
Africa, Latin America, as well as Asian countries like Japan, Korea, China,
Pakistan, Bangladesh, Nepal, and Sri Lanka. Our goal is to transform into a
multinational company, from being a multi-state player, in the near future by
setting up centers in crucial global locations. This strategic move will give
us a substantial advantage in expanding our global presence and operations.We
acknowledge our responsibility in promoting global health equity, which serves
as a driving force for us to continuously enhance access to life-saving
medications worldwide by aligning with varied rigorous delivery schedules.What are Metrochem API’s growth plans?Our
objective is to become the foremost choice as an API supply chain partner. We
plan to broaden our customer base through exceptional product quality and
delivery services. At the same time, we aim to strengthen our global reputation
as the most respected API partner, while
diversifying our product portfolio to include candidates among varied
therapeutic segments.In
addition to having a product portfolio covering 30 different therapeutic
segments, we have taken steps to enter the field of oncology by establishing a
dedicated facility for the production of oncology APIs. Furthermore, we plan to
start manufacturing steroids and peptides soon. Our vision includes expanding
into biopharmaceutical manufacturing within the next five years, all while
maintaining our commitment to core small molecule API production.Our goal is to achieve sustainable growth and establish ourselves as a leader in bulk drugs, catering to various market segments. To achieve this objective, we are actively working on developing an agile operational system that is aligned with our goals.
Impressions: 2876
https://www.pharmacompass.com/speak-pharma/we-are-working-towards-providing-affordable-high-quality-apis
#SpeakPharma with Metrochem
09 Oct 2023
This week, Speakpharma interviews Dr. Jagadeesh Babu Rangisetty, CEO of Biophore India Pharmaceuticals. The Hyderabad (India)-based company has four US Food and Drug Administration (FDA) and European Union inspected manufacturing facilities for active pharmaceutical ingredients (APIs) situated in Visakhapatnam, one dedicated intermediate facility and a world-class R&D lab housing 500 scientists with varied expertise. Now, the company hopes to emerge as the most trusted organization in the complex and niche pharmaceutical molecule segments.Can you provide an overview of Biophore’s expertise in developing complex APIs?Since our inception in 2007, Biophore has established itself as a company that focuses extensively on R&D to deliver exceptional value and end-to-end solutions to our clients.In 2010, we filed
our first DMF (drug master file) in the US. Since then, we have successfully
filed over 120 DMFs in the US and over 25 Certificates of Suitability (issued
by the European Directorate for the Quality of Medicines), along with
regulatory filings across Canada, China, Korea, Middle East and North Africa
(MENA) and other global markets. Over the past five years, we have consistently
ranked among the top 5 DMF filers.Our primary focus
is to leverage our research strength and deliver products with complex
chemistry and high entry barriers to our clients. Over the years, we have developed such an
expertise in niche and complex products and our customers look to us when it
comes to critical products.We operate four world-class facilities that allow us to cover a wide range of therapeutic areas. Currently, Biophore serves over 300 customers, including several top 20 pharmaceutical companies.Can you explain the role of Biophore’s state-of-the-art technology development center in development of these products?Our state-of-the-art technology development center, situated in Hyderabad (India), plays a central role in advancing the development of niche pharmaceutical products. It serves as a research and innovation hub, allowing us to generate new ideas, work on them and deliver a robust product fit for the global markets.The center is
equipped with specialized laboratories for various therapeutic segments, such
as peptides and oncology products and also has sophisticated analytical
instruments that facilitates complex API characterizations. Our dedicated
research team is working on over 20 development projects at any given time.What are some of the key therapeutic areas that Biophore focuses on?Biophore focuses on several niche and complex therapeutic areas such as oncology, peptides, contrast media, colored APIs, hormonals, iron products, and injectable APIs. We have deep expertise in delivering time bound APIs to the market. We are also recognized as a global leader when it comes to products for orphan indications to provide treatment options for rare diseases.What are some of the challenges being faced by Biophore, and how does
the company address them?The generic industry has been facing challenges of late due to various factors. These include intense price pressures, supply chain disruptions and increasing competition.To tackle these
obstacles, we have implemented a range of strategies. One, we have adopted a
backward integration approach for intermediates that gives us greater control
over the supply chain and reduces our reliance on external sources. Two, rather
than focusing on a single market for all our products, we target multiple
global markets. This approach mitigates risks associated with market
fluctuations and regulatory changes.Additionally, we
place significant emphasis on delivering new and distinctive products. By
offering a unique product portfolio, we set ourselves apart from our competitors,
establish a competitive advantage and attract a broader customer base.
Impressions: 2705
https://www.pharmacompass.com/speak-pharma/we-want-to-emerge-as-the-most-trusted-api-firm-in-complex-drug-molecule-segments
#SpeakPharma with Biophore
30 Sep 2023
This week, SpeakPharma interviews Ella Qu, General Manager & Director at China-headquartered Boai NKY Pharmaceuticals Limited, one of the world’s largest manufacturers of polypyrrolidone (PVP) and PVM/MA copolymer. While PVP is extensively used in the pharmaceutical industry as a binder in tablet manufacturing, PVM/MA copolymer is widely used in the cosmetic industry. In this interview, Ms. Qu talks about the company’s history, its product range and commitment to adopting green manufacturing practices.Can you tell us a bit about Boai NKY Pharma — its genesis, specializations and growth trajectory?Boai NKY Pharmaceuticals
Limited was established in 1987. Back then, it was the first domestic company to develop and manufacture polyvinylpyrrolidone (PVP), a versatile ingredient used in pharmaceutical and cosmetic industries. In 2003, we got converted into a shareholding company.Innovation has
been key to our growth strategy. In 2008, we researched and developed PVM/MA
copolymer products. PVM/MA copolymer is an ingredient commonly used in oral
care products such as denture adhesive, toothpaste, and can also be used in
pharmaceutical applications.During the same
period, we set up Tianjin Boai NKY International Limited, a whole share
subsidiary company of Boai NKY. It operates all our international business.In 2010, we were
publicly listed on the Shenzhen Stock Exchange. In 2015, we were certified by
EXCiPACT GMP, a certification accepted by all major regulators around the
world. In fact, we were the first manufacturer in China to obtain this
certification. And in May this year, NKY Pharma became one of the largest PVP
producers in the world and one of the largest producers of PVM/MA products in
the world.What have been the reasons behind this
success?NKY Pharma has
always been dedicated to research and development. We have continuously worked
towards introducing professionals in our company, and have strived to improve
quality, to provide better service, to be more transparent and open to our
customers.I attribute our success
to these factors, and to our customers. Our aim has always been to establish
mutually beneficial partner relationships. Going forward, our strong customer
support coupled with our development in products and processes will stand us in
good stead.How are you addressing the needs of
customers spread across continents?Boai NKY Pharma
has established its subsidiaries in Europe and the US. With the setting up of
branch offices and warehouses, Boai NKY Pharma is able to communicate with its
customers in a timely and effective manner.Could you provide more information about
your product line, particularly KoVidone® and PolyKoVidone® lines of pharmaceutical excipients?KoVidone® and PolyKoVidone® polyvinylpyrrolidone (PVP) are widely used in the pharmaceutical
field as excipients and are suitable for a broad range of dosage forms. KoVidone® K series products possess excellent
binding, film-forming, dispersing and thickening properties and are widely used
in the following dosage forms:• As a binder: These products are suitable for wet and dry granulation and direct compression in tableting. KoVidone® K improves particle compressibility and
can be added to powder blends in dry or granulated forms through the addition
of water, alcohol or hydro-alcoholic solutions.• As a solubilizer: These products are suitable for oral and parenteral formulations, enhancing the solubility of poorly soluble drugs in solid dispersion forms.• As a coating agent or binder: These products are suitable for coating of active pharmaceutical ingredients (APIs).• As a suspending, stabilizing or viscosity-modifying agent: These products are suitable for topical and oral suspension and solution applications. The solubility of poorly soluble drugs can be enhanced through the use of KoVidone®.KoVidone® also works as a
viscosity modifier in tablet coatings. The addition of KoVidone® K30 to HPMC (hydroxypropyl
methylcellulose) formulated film coating solutions can effectively reduce the
viscosity of the HPMC solution while not affecting the resultant hydration
profile of the resultant film.PolyKoVidone® possesses dual
binding and disintegration properties, and enhances active solubilization. The
product is used in the following applications: • Super disintegrant: Due to its excellent swelling characteristics in water, PolyKoVidone® can be used as a water-insoluble
disintegrant for wet and dry granulation processes. The material can be added
either before or after granulation in direct compression tableting processes.
It exhibits high capillary activity and pronounced hydration capacity, without
the formation of gel.• Solubility enhancer: PolyKovidone® increases the solubility of poorly
soluble drugs via co-evaporation processes.• Suspension stabilizer: PolyKoVidone® increases viscosity and improves the
dispersion properties to reduce the sedimentation rate of drugs, while
increasing the re-dispersibility of said sediment. It is suitable for liquid
and instant oral preparations.• Complexing agent of drug ingredients: PolyKoVidone® stabilizes
active ingredients in pharmaceutical products, thereby improving drug
solubility and bioavailability.How is Boai NKY Pharma committed to the
development of green production processes?As a young company, the top management of Boai NKY Pharma has laid out a long-term planning and development strategy. We follow all environmental compliances mandated by the government.We are working
towards making our production processes green through ways such as real time
monitoring of waste streams, 100 percent recycling of processing water, and by
switching from coal to natural gas.We are working with associations that are dedicated to sustainable development. Our growth and developmental goals will always be aligned with our commitment to environmental sustainability.
Impressions: 2137
https://www.pharmacompass.com/speak-pharma/we-owe-our-success-to-our-focus-on-r-d-quality-and-better-service
#SpeakPharma with Boai NKY
27 Sep 2023
Over the recent years, the market for contract development and manufacturing organizations (CDMOs) has been growing at a fast clip owing to a plethora of factors such as the rising demand for biologics, new trends towards personalized medicines and the need to bring new treatments to the market more quickly. This week, SpeakPharma interviews Dawid Ignatowicz, Head of Key Account Management, CDMO, Polpharma, to know how the Polish drugmaker is growing its CDMO business and some of the inherent advantages it enjoys in this landscape.
Of late, there has been an increase in
demand for drug substance development and cGMP manufacturing services. How is
Polpharma gearing up to meet this demand?
In fact, the number of drug developments has increased over the past few years. This coupled with some lack of capacity in some major European CDMO’s, potentiates good opportunities for companies like Polpharma.
Over the last few
years, Polpharma has been growing its offer on the CDMO, either by adding new
capabilities in research and development and in production or by increasing its
manufacturing standards (compliance, EHS, etc.).
Our objective is to support our customers into the different phases of drug development, as such we have adapted our systems to be able to answer their requirements on the different stages – with the ultimate goal of providing a reliable, efficient, and cost-effective service to the customers.
What differentiates Polpharma from other
CDMOs?
Our major
strengths can be referred as: good project management skills (we have a group
of experienced people that help the customers), transparency (since the
inception of a project we have developed a clear and transparent way of
communicating flow with the customer so that we can have full visibility of
their project in our site), an ability to listen to our customers (a rather
simple requirement, but that seems difficult to find in the market), good
process design (more delivery kilos of a product we want to establish a good
efficient and cost-effective process) and flexibility (we understand that
development projects could have changes on the timelines and the capability to
adapt to those changes is critical).
Besides the above, we have a positive track record of regulatory approvals coupled with experience and expertise in filing to the FDA. We have positive pre-approval inspection audits (PAIs) that reaffirm our robust quality management system. We are known for efficient management of changes and deviations — we are both open and collaborative and work alongside our clients.
Tell us about the range of CDMO projects
that Polpharma handles.
Owing to our decades-long experience in drug substance development, regulatory filing, and commercial manufacturing, Polpharma can support customers at various phases — from clinical supplies, through validation and launch, up to regular commercial supplies.
Manufacturing highly potent APIs comes
with several challenges, especially with respect to toxicity and exposure. Are
you observing more projects with high toxicity?
In order to address the growing demand for the development and manufacture of highly active compounds, we have invested over €35 million in a new facility to handle HPAPIs that will include process and analytical R&D, small-scale cGMP manufacturing suites and quality control (QC) labs. This facility will allow us to handle compounds with an occupational exposure limit (OEL) value down to 10 ng/m3 (or OEB6, i.e. very high contamination).
Impressions: 2536
https://www.pharmacompass.com/speak-pharma/polpharma-has-invested-over-35mln-euros-in-a-completely-new-facility-to-handle-hpapis
#SpeakPharma with Polpharma
11 Sep 2023
This
week, SpeakPharma interviews Peter Werth, President and CEO of ChemWerth, a full-service generic drug development and supply firm that is celebrating its 40th year in business. On this milestone anniversary, Werth discusses the drugmaker’s plans to expand its manufacturing partnerships in China and India. These investments will further diversify its supply and portfolio, help develop new generic APIs, mitigate the risk of supply chain disruptions, and position ChemWerth to meet the increasing global demand for generic pharmaceuticals, says Werth.With ChemWerth turning 40, what are your thoughts on the company’s journey?We
have had an interesting journey thus far. After being founded in 1983, we filed
our first Drug Master File (DMF) with the US Food and Drug Administration (FDA)
in 1987. We have come a long way since then, having established ourselves as
specialists in product selection and development, analytical and regulatory
services, as well as project management.Today,
we are a leading supplier of generic active pharmaceutical ingredients (APIs)
for human and animal health markets worldwide, with a presence in 38 countries.
We have access to over 500 APIs from more than 30 manufacturing facilities
worldwide. We also act as a regulatory agent for more than 25 facilities
approved by the FDA in the US, Europe, India, and China. We have partnerships
in several countries and sell more than 100 products worldwide.The year 2020 was a landmark year for us, as we filed our 500th DMF with the FDA. It strengthened our position as one of the world leaders in filing DMFs. Our average review cycle for DMF filings is just 0.79, which is much lower than the industry average of 2.5 cycles. This allows our customers to reach the market much faster, which in turn gives them a substantial competitive advantage over their competitors.With our
reputation for supplying reliable, high-quality, non-infringing APIs at
competitive prices, we have earned the trust of some of the largest generic
pharmaceutical companies. Our continued growth and success are the result of
our commitment to quality, our exceptional regulatory services, and our ability to adapt to changes in the pharmaceutical
industry.In
this year of our 40th anniversary, we’re entering an exciting period of growth. We are expanding our manufacturing footprint worldwide.Can you elaborate on these expansion plans?We have decided to invest millions of dollars in expanding our manufacturing partnerships in China and India. This will help us diversify our portfolio as well as our supply chain.Through
our investments in our joint-venture facilities in India and China, we want to
show our commitment towards delivering affordable medicines to patients all
around the world. This expansion will also help us develop new generic APIs,
mitigate the risk of supply chain disruptions, and meet the increasing demand
for generic medicines worldwide.All our partner manufacturers that currently produce steroid, hormone and veterinary products and large-volume APIs and small-molecule inhibitors will benefit from the new investments. We will also create new jobs for highly skilled workers such as scientists, engineers, and manufacturing personnel.In addition to hiring employees, these investments will cover training that is required to raise compliance and quality to current good manufacturing practice (CGMP) standards and will be used to purchase new equipment.What’s the growth rate of the global generic drug market? How is ChemWerth planning to
capitalize on this growth?The
global generic drugs market is growing at a healthy pace. According to Precedence Research, a company that provides strategic market insights, the global market for generic drugs is poised to grow at a compounded annual growth rate (CAGR) of 5.4 percent, growing from US$ 439.37 billion in 2022 to US$ 670.82 billion by 2030. There are several factors contributing to this growth, such as the low cost of generics, expiration of patents of branded drugs, and increasing prevalence of chronic diseases.The pandemic led to supply chain disruptions that created
drug shortages worldwide. How did ChemWerth mitigate the risk of supply chain
disruptions?Yes, the pandemic
was marked by supply chain disruptions that drove demand to unprecedented
highs. During those days, ChemWerth relied on its experience and expertise in working with the FDA in order to gain necessary approvals and get the products on the market quickly. Our experienced team worked tirelessly to ensure that the supply of essential drugs was maintained, new drugs were developed to address emerging needs, and compliance remained at a high level.We
monitored the global supply chain very closely, developed contingency plans,
and diversified our manufacturing partnerships to reduce the risk of supply
chain disruptions. As a result of these efforts, we successfully met the
increased demand for pharmaceuticals during the pandemic and continued to
deliver high-quality, affordable drugs to patients worldwide.At
ChemWerth, we have a highly experienced team of regulatory and compliance
experts who work closely with the FDA to ensure successful DMF approvals. We
are proud of our track record of routinely gaining DMF approvals on the first
pass. This places us among the best-in-class companies that are in the 12
percent approval group.In the future too, we intend to work on mitigating supply chain disruptions and provide high-quality generic pharmaceutical products to patients worldwide.
Impressions: 2768
https://www.pharmacompass.com/speak-pharma/we-are-diversifying-by-expanding-our-manufacturing-partnerships-in-china-india
#SpeakPharma with ChemWerth
02 Jun 2023
